Knotless collapsible sutures and methods for suturing

ABSTRACT

Various exemplary methods and devices are provided for improved surgical sutures, suture systems, and methods for suturing. In general, the sutures, suture systems, and methods can allow a suture to form a secure, closed loop without tying a knot. The suture can include a barbed portion configured to be threaded through a hollow portion. The barbed portion can have a plurality of barbs thereon, which can grasp onto an inner wall of the hollow portion when disposed therein to help secure the loop at a desired size. The barbs can all be oriented in one direction that corresponds to a direction of movement of the suture when the loop is being tightened. Thus, the barbs can be configured to allow for a size of the loop to be easily reduced to any desired size to approximate tissue, but can be configured to resist subsequent expansion of the loop to ensure that the tissue remains in place.

CROSS REFERENCE TO RELATED APPLICATION

The present application is a continuation of and claims priority to U.S.patent application Ser. No. 15/243,728, filed Aug. 22, 2016, andentitled “KNOTLESS COLLAPSIBLE SUTURES AND METHODS FOR SUTURING,” whichis a divisional of and claims priority to U.S. patent application Ser.No. 14/102,915, filed Dec. 11, 2013, and entitled “KNOTLESS COLLAPSIBLESUTURES AND METHODS FOR SUTURING,” and which issued as U.S. Pat. No.9,451,953 on Sep. 27, 2016, the contents of each which is herebyincorporated by reference in their entireties.

FIELD

The present disclosure relates generally to surgical sutures, suturesystems, and methods for suturing.

BACKGROUND

The rotator cuff, a group of four muscles that wrap around the shoulderjoint to attach the upper arm to the shoulder blade, in part allows theshoulder to move and turn through a wider range than any other joint inthe body. Unfortunately, tears of the rotator cuff are common, makingmany routine activities difficult and painful.

Rotator cuff tears are treated through physical rehabilitation withlimited success, and as such, surgery is often necessary to correct thefunction of the muscle group. Rotator cuff repair surgery can be doneeither through a traditional large incision, or arthroscopically usingthree to four small incisions and a keyhole camera. Large surgicalincisions can cause significant pain and require lengthy recovery times,and thus arthroscopic procedures are generally preferred.

Although the goal to re-attach the torn rotator cuff muscle is the sameusing all methods, decreasing the size of the incision used increasesthe level of surgical skill required. It can be difficult to manipulatesutures and properly adjust the tension of suture knots within thesurgical site using arthroscopic techniques. Further, knots and otherbulky attachment means can irritate tissue over time. Sutures can besimilarly difficult to secure and/or similarly irritating to tissue inother surgical applications, such as in anterior cruciate ligament (ACL)repair.

Accordingly, there is a need for improved surgical sutures, suturesystems, and methods for suturing.

SUMMARY

Sutures, suture systems, and methods are generally provided for securingtissue to adjacent tissue and/or to bone. In one embodiment, a suturingsystem is provided that includes a flexible suture having leading andtrailing ends. The suture can have a first partial longitudinal lengthwith a plurality of unidirectional barbs, and a second partiallongitudinal length having a hollow portion. The hollow portion can belocated between the trailing end of the suture and the plurality ofunidirectional barbs, and the leading end of the suture can beconfigured to pass through the hollow portion so as to move at least oneof the barbs into the hollow portion such that the at least one of thebarbs grasps onto the suture within the hollow portion thereof. In someembodiments, the suture can be a single strand including the barbs andthe hollow portion.

The suturing system can have various configurations. In someembodiments, the barbs can be configured to grasp soft tissue so as toprevent movement of the suture relative to the soft tissue in adirection opposite to the unidirection of the barbs. In someembodiments, when the at least one of the barbs are positioned withinthe hollow portion, the first partial longitudinal length can be coaxialwith the hollow portion of the second partial longitudinal length. Insome embodiments, the first partial longitudinal length of the suturecan be longer than the hollow portion of the second partial longitudinallength of the suture. The suture can include a third partiallongitudinal length that extends between the barbs and the leading end.The respective lengths can vary, and in one embodiment the third partiallongitudinal length can be longer than each of the first and secondpartial longitudinal lengths of the suture.

The system can include a threader positioned within the hollow portionof the suture. The leading end of the suture can be configured to mateto the threader, which can be configured to be pulled through the hollowportion of the suture with the leading end mated therewith so as to passthe leading end of the suture into the hollow portion and move theleading end therethrough such that at least one of the barbs is movedinto the hollow portion.

The system can include a cannula. The suture can be configured to passthrough the cannula, into a soft tissue, and back through the cannula soas to position a free end of the suture outside the cannula and toposition the barbs outside the soft tissue. The free end of the suturethat is positioned outside the cannula can be configured to be movedrelative to the cannula so as to move the barbs into the soft tissue andinto the hollow portion of the suture.

In another embodiment, a suturing system is provided that includes aflexible suture having a free end configured to enter into a hollowportion of the suture and pass through the hollow portion in a firstdirection so as to move a plurality of unidirectional barbs extendingoutward from the suture along a length of the suture into the hollowportion. The barbs can be configured to grasp onto the suture within thehollow portion so as to prevent the length of the suture from movingwithin the hollow portion in a second direction that is opposite to thefirst direction.

The system can vary in a number of ways. In some embodiments, the barbscan extend along a length of the suture that is greater than a length ofthe hollow portion such that all of the barbs cannot be simultaneouslypositioned within the hollow portion. In some embodiments, the barbspositioned within the hollow portion that grasp onto the suture withinthe hollow portion can be configured to lock the length of the suture ina fixed position relative to the hollow portion of the suture. In someembodiments, a length of the suture can be positioned within the hollowportion, and the length of the suture can be coaxial with the hollowportion of the suture. In some embodiments, the barbs can be configuredto grasp soft tissue so as to prevent movement of the suture relative tothe soft tissue in a direction opposite to the unidirection of thebarbs.

The system can include a threader that can be positioned within thehollow portion of the suture. The free end of the suture can beconfigured to mate to the threader, which can be configured to be pulledthrough the hollow portion with the free end mated therewith so as topass the free end of the suture into the hollow portion and position oneor more of the barbs within the hollow portion.

The system can include a cannula. The suture can be configured to passthrough the cannula, into a soft tissue, and pass back through thecannula so as to position a free end of the suture outside the cannulaand to position the barbs outside the soft tissue. The free end that ispositioned outside the cannula can be configured to be moved relative tothe cannula so as to move the barbs into the soft tissue and into thehollow portion of the suture.

In another aspect, surgical methods are provided that in one embodimentincludes advancing a leading end of a suture into a first tissue,advancing the leading end of the suture into a second tissue, andadvancing the leading end of the suture into a hollow portion of thesuture so as to form a loop. The method can also include pulling theleading end of the suture relative to the hollow portion, the firsttissue, and the second tissue so as to advance a plurality ofunidirectional barbs formed on the suture through the first tissue,through the second tissue, and into the hollow portion. The plurality ofunidirectional barbs can grasp the second tissue and can grasp thesuture within the hollow portion so as to lock the suture in positionrelative to the first and second tissues.

The method can have any number of variations. In some embodiments, alength of the suture extending through the hollow portion can be coaxialwith the hollow portion. In some embodiments, the leading end of thesuture can be advanced into the hollow portion of the suture after theleading end of the suture has been advanced into the first tissue andadvanced into the second tissue. In some embodiments, the method canalso include advancing the leading end of the suture through a cannulaprior to advancing the leading end into the first tissue, and advancingthe leading end of the suture back into the cannula after advancing theleading end into the second tissue. In some embodiments, pulling theleading end of the suture can cause the first and second tissues to bedrawn together.

BRIEF DESCRIPTION OF DRAWINGS

This invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a side schematic view of one embodiment of a suture, thesuture having a threader mated thereto;

FIG. 2 is a side schematic view of a portion of the suture of FIG. 1with end portions of the suture being locked together;

FIG. 3A is side schematic, partial cross-sectional view of the sutureand the threader of FIG. 1 extending through a cannula, a first tissue,and a second tissue;

FIG. 3B is a side schematic, partial cross-sectional view of the suture,the threader, and cannula of FIG. 3A with a free end of the suturepassed through the threader;

FIG. 3C is a side schematic, partial cross-sectional view of the sutureand the cannula of FIG. 3B showing the threader removed and a portion ofthe suture extending through another portion of the suture to form aloop; and

FIG. 3D is a side view of the suture and cannula of FIG. 3C showing theloop tensioned to secure the first and second tissues to one another.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention.

To the extent that linear or circular dimensions are used in thedescription of the disclosed systems, devices, and methods, suchdimensions are not intended to limit the types of shapes that can beused in conjunction with such systems, devices, and methods. A personskilled in the art will recognize that an equivalent to such linear andcircular dimensions can easily be determined for any geometric shape.Sizes and shapes of the systems and devices, and the components thereof,can depend at least on the anatomy of the subject in which the systemsand devices will be used, the size and shape of components with whichthe systems and devices will be used, and the methods and procedures inwhich the systems and devices will be used.

Various exemplary methods and devices are provided for improved surgicalsutures, suture systems, and methods for suturing. In general, thesutures, suture systems, and methods can allow a suture to form asecure, closed loop without tying a knot. The suture can include abarbed portion that is configured to be threaded through a hollowportion of the suture to form a closed loop. The barbed portion can havea plurality of barbs thereon, which can be configured to grasp onto aninner wall of the hollow portion when disposed therein to help securethe loop at a desired size. Multiple barbs can be disposed within thehollow portion when the loop is at the desired size, thus creatingmultiple points of contact between the barbed and hollow portions. Thiscan increase a load-bearing capacity of the loop and/or can reduce arisk of the loop being loosened. To further help secure the loop ofsuture at the desired size, the barbs can all be oriented in onedirection that corresponds to a direction of movement of the suture whenthe loop is being tightened. Thus, when the suture is moved and/ortensioned in the direction of the barbs, the barbs can be configured toallow for the barbed portion to pass easily through the hollow portion.When the suture is tensioned in a direction that is opposite to thedirection of the barbs, the barbs can be configured resist movement ofthe barbed portion within the hollow portion. In this way, the barbs canbe configured to allow for a size of the loop to be easily reduced toany desired size to approximate tissue, but can be configured to resistsubsequent expansion of the loop to ensure that the tissue remains inplace.

In an exemplary embodiment, shown in FIG. 1, a suture 100 can include abarbed portion 108 and a hollow portion 112 disposed between a leadingend 102 and a trailing end 104 of the suture 100. Interspersed betweenthe barbed and hollow portions 108, 112, there can be non-hollowportions of varying lengths. As in the illustrated embodiment, thesuture 100 can include a non-hollow leading portion 106 adjacent to theleading end 102, a non-hollow intermediate portion 110 disposed betweenthe barbed portion 108 and the hollow portion 112, and a non-hollowtrailing portion 114 disposed between the hollow portion 112 and thetrailing end 104. Both the leading and barbed portions 106, 108 can beconfigured to be threaded through the hollow portion 112 to form aclosed loop. When barbs 118 of the barbed portion 108 are disposedwithin the hollow portion 112, they can grasp onto the hollow portion112 to secure the loop at a desired size. In this way, the suture 100can have a self-locking mechanism, in which one portion of the suture100, e.g., the hollow portion 112, is configured to lock to anotherportion of the suture 100, e.g., the barbed portion 108, without the useof a knot and/or any other attachment mechanisms, e.g., adhesive, clips,etc.

The suture 100 can have a variety of shapes and sizes. In general, thesuture 100 can be configured to pass through tissue. The suture 100 canhave any length sufficient to allow for the suture 100 to be manipulatedby a user and passed through tissue, as will be appreciated by a personskilled in the art. The suture 100 can have any width, either constantor varying, along the length of the suture 100. In one exemplaryembodiment, a width of one or both of the barbed portion 108 and theleading portion 106 can be less than a width of the hollow portion 112,which can facilitate passage of the leading and barbed portions 106, 108through the hollow portion 112. Although the suture 100 is a singlestrand in the illustrated embodiment, the suture 100 can include morethan one suture strand. By way of non-limiting example, the leadingportion 106 and/or the barbed portion 108 can include a second suturestrand that is attached to a first suture strand that includes thehollow portion 112.

The suture 100 can be made from any one or more materials, as will beappreciated by a person skilled in the art. The material(s) can beflexible such that the suture 100 is sufficiently flexible to allow thebarbed and leading portions 108, 106 to pass through the hollow portion112 and to form a loop of a desired size.

The barbed portion 108 of the suture 100 can extend along any length ofthe suture 100. In the illustrated embodiment, the barbed portion 108extends along a partial length L2 of the suture 100. The barbedportion's length L2 can be sized in accordance with a type of tissuethat the suture 100 can be configured to approximate and/or can be sizedsufficiently large to tolerate a range of tissue thicknesses. Forexample, the barbed portion's length L2 can be large so as to facilitateuse of the suture 100 with very thick tissue and/or different types oftissue. The barbed portion's length L2 can be larger than a length L4 ofthe hollow portion 112, as in the illustrated embodiment, such that allof the barbs 118 disposed on the barbed portion 108 cannot be disposedwithin the hollow portion 112 at the same time. Because it can bedifficult to predict a desired size of the loop prior to the loop beingformed and tightened, a longer length L2 of the barbed portion 108 canhelp ensure that at least some of the barbs 118 are disposed within thehollow portion 112 when the loop is reduced to the desired size. In anexemplary embodiment, the relative lengths L2 and L4 of the barbedportion 108 and the hollow portion 112 can be sized to allow for thebarbed portion 108 to extend coaxially all the way through the hollowportion 112 when the suture 100 is arranged in a loop of the desiredsize, thus maximizing the number of barbs 118 contained within thehollow portion 112 so as to help securely form the loop and preventslippage thereof. Any barbs 118 that are not encompassed in the hollowportion 112 can dig into tissue through which the suture 100 passes,further helping to secure the loop of the suture 100 against movementrelative to the tissue.

The leading, intermediate, and trailing portions 106, 110, 114 can eachhave any length. The leading portion 106 can have a length L1 that isgreater than each of the lengths L2 and L4 of the barbed and hollowportions 108, 112, respectively. The larger the leading portion's lengthL1, the easier it can be for a user to manipulate the suture 100 to passthe suture 100 through tissue. Particularly during arthroscopicprocedures, where the tissue to be approximated can be located far froma surgical opening, a large length L1 of the leading portion 106 canfacilitate manipulation of the suture 100 through the tissue. By way ofnon-limiting example, where a cannula is used to access a surgical site,as discussed further below, the leading portion's length L1 can be largeenough to allow for the suture 100 to pass down through the cannula,through the target tissue, and back up through the cannula with thebarbs 118 and/or the leading end 102 positioned entirely outside thecannula. This can help to reduce a risk of incidental damage to thetissue by the barbs 118. The intermediate and trailing portions 110, 114can have lengths L3 and L5, respectively, which can each be less thanthe length L1 of the leading portion 106.

In an exemplary embodiment, the length of the suture 100 can be in arange of about 100 to 1500 mm, the length L2 of the barbed portion 108can be in a range of about 10 to 100 mm, the length L4 of the hollowportion 112 can be in a range of about 5 to 50 mm, e.g., in a range ofabout 5 to 10 mm, the length L1 of the leading portion 106 can be in arange of about 100 to 1500 mm, the length L3 of the intermediate portion110 can be in a range of about 1 to 100 mm, and the length L5 of thetrailing portion 114 can be in a range of about 5 to 25 mm.

The hollow portion 112 can generally be configured to allow for passageof the length L1 of the leading portion 106 and a partial length of thebarbed portion 108 therethrough and to allow for securing the barbedportion 108 therein. The barbed portion 108 can be configured to bepositioned coaxially within the hollow portion 112, as shown in FIG. 2.As also shown in FIG. 2, the hollow portion 112 can have an innerpassageway 116 that extends longitudinally therethrough. The passageway116 can be wide enough and long enough to coaxially seat at least aportion of the barbed portion 108 therein. Similarly, an outer wall 115of the hollow portion 112 can be configured to allow for passage of thebarbed portion 108 therethrough. A weave of the wall 115 of the hollowportion 112 can be loose enough to allow for passage of the barbedportion 108 through the wall 115 of the hollow portion 112. In someembodiments, e.g., where the hollow portion 112 is a braided suture, aweave of the hollow portion 112, e.g., of the braid, can be loose enoughto allow for the barbs 118 to stick out of hollow portion 112 andthrough the wall 115 when the barbed portion 108 is seated coaxiallywithin the hollow portion 112, which can help to further secure thesuture 100 to tissue by allowing the barbs 108 extending through thewall 115 to dig into the tissue. The hollow portion 112 can be made fromone or more materials that can be different from one or more materialsused to make the barbed portion 108 and/or the leading portion 106. Inone embodiment, the hollow portion 112 can be made from one or morematerials sufficiently flexible to allow for expansion and restrictionof the passageway 116 and/or of spaces in the wall 115 as the barbedportion 108 passes therethrough. In an exemplary embodiment, the hollowportion 112 can be the Ethibond™ #5 coreless suture, available fromEthicon, Inc. of Somerville, N.J., with its core removed.

The barbed portion 108 can have a plurality of barbs 118 thereon. Therecan be any number of barbs 118, oriented in any pattern along the lengthL2 of the barbed portion 108. In the illustrated embodiment, there areeight pairs of barbs 118, each pair extending from the same longitudinalposition on the suture 100 and from opposite sides of the suture 100.The barbs 118 can be long enough and wide enough to grasp onto thehollow portion 112 when the barbed portion 108 is disposed thereinand/or to grasp onto tissue through which the barbed portion 108 passes.The barbs 118 can be small enough to allow for passage of the barbedportion 108 through the passageway 116 and the wall 115 of the hollowportion 112. In an exemplary embodiment, only the barbs 118 of thebarbed portion 108 can extend through the wall 115 when the barbedportion 108 is positioned within the hollow portion 112, such that acore portion of the barbed portion 108 from which the barbs 118 extendcan be contained within the hollow portion 112. The barbs 118 can beunidirectional, such as in the illustrated embodiment in which the barbs118 all extend radially outward from the suture 100 in a first directionD1. The first direction D1 can correspond to a direction in which thesuture 100 is moved to tighten a loop of the suture 100. The barbs 118can extend at an angle α relative to the suture 100, which can be anyangle, either the same or different from one another. In an exemplaryembodiment, all of the barbs 118 can extend outwardly from the suture100 at the same angle α. The angle α must be small enough to allow forpassage of the barbs 118 through the wall 115 and the passageway 116 ofthe hollow portion 112 when the barbed portion 108 is moved through thehollow portion 112 in the first direction D1, but must be large enoughto cause the barbs 118 to catch on the wall 115 and/or the passageway116 when the barbed portion 108 stops being moved through the hollowportion 112 and if the suture 100 is pulled in a second direction D2that is opposite to the first direction D1. Thus, the barbs 118 canallow for a size of the loop to be easily reduced to any desired size toapproximate tissue but can resist subsequent expansion of the loop toensure that the suture 100 remains in place relative to the tissue. Thebarbs 118 can be arranged in any pattern along the length of the suture100, in any longitudinal position and at any angle α to achieve adesired amount of resistance to movement in the second direction D2.

FIG. 2 illustrates the barbed portion 108 passed coaxially through thehollow portion 112. As shown in FIG. 2, the barbs 118 can dig into thewall 115 along multiple points of contact to resist movement of thesuture 100 in the second direction D2 so as to help prevent expansion ofthe size of the loop. The barbs 118 can also be configured to helpsecure the suture 100 to tissue. As mentioned above, in someembodiments, the barbs 118 can pass through the wall 115 of the hollowportion 112 and into tissue when the barbed portion 108 is disposedcoaxially within the hollow portion 112, such as if the hollow portion'sweave is loose and/or the barbs 118 are sufficiently long. All of thebarbs 118, including the barbs 118 disposed within the hollow portion112 and any barbs 118 disposed outside the hollow portion 112, canassist in securing the suture 100 to tissue, thereby helping to fix thetissue in an approximated position. In embodiments in which the lengthL2 of the barbed portion 108 is greater than the length L4 of the hollowportion 112, some of the barbs 118 can be positioned within the hollowportion 112 throughout the hollow portion's length L4, while others ofthe barbs 118 are positioned outside the hollow portion 112. These barbs118 outside the hollow portion 112 can dig directly into tissue, asmentioned above. Depending on a size of the loop, the barbs 118 may notbe positioned within the hollow portion 112 throughout its entire lengthL4, e.g., if a small loop is formed. In embodiments in which the lengthL2 of the barbed portion 108 is equal to or less than the length L4 ofthe hollow portion 112, all of the barbs 118 can be positioned withinthe hollow portion 112, as in the embodiment of FIG. 2 in which thebarbed portion's length L2 is less than the hollow portion's length L4.

In some embodiments, the barbs 118 can be attached to the suture 100 viahinges (not shown). The hinges can be disposed at roots R of each of thebarbs 118 (see FIG. 1). The hinges can be configured to facilitatecollapsing of the barbs 118 radially inward against the suture 100 whenthe suture 100 is moved and/or tensioned in the first direction D1, andthe hinges can be configured for the barbs to extend radially outwardwhen the suture 100 is moved and/or tensioned in the second directionD2. The hinges can be biased such that the barbs 118 are biased toextend radially outward. The hinges can allow for rotational movement ofthe barbs 118 through a variable angular range with respect to thesuture 100, for example from zero degrees up through the angle α.Additionally or alternatively, the suture 100 can have notches formedtherein at the roots R, which can help to accommodate the barbs 118 whenthe barbs 118 are moved radially inward, e.g., when the suture 100 ismoved and/or tensioned in the first direction D1. The notches can besized such that the barbs 118 can be flush or substantially flush withthe core portion of the barbed portion 108 when the barbs 118 arecollapsed. The barbs 118 can be manufactured by stamping, and thenotches can be formed in the barbs 118 during this stamping.

The barbs 118 can be made from one or more materials. The materials canbe sufficiently rigid to allow the barbs 118 to securely grasp the wall115 and/or tissue. Examples of the materials include plastics, e.g.,polypropylene, prolene, etc, and/or metals, e.g., titanium, stainlesssteel, etc. The barbs 118 can have a filament threaded therearound tostrengthen the barbs 118. The filament can be made from any one or morematerials, but must be sufficiently thin to allow for passage of thebarbed portion 108 through the passageway 116 and/or the wall 115 of thehollow portion 112. One exemplary suture that can be used as the barbedportion 108 is the Ethicon Stratafix™ barbed suture, available fromEthicon, Inc. of Somerville, N.J. The Stratafix™ barbed suture includesa barbed polymer or metal structure with a suture material, e.g.,polyester, braided over the barbed polymer. The suture material can bebraided over a partial or entire length of the polymer.

The suture 100 can be configured for use with a number of surgicaldevices and in a number of surgical procedures. By way of non-limitingexample, a threader 120 can be used to splice the hollow portion 112 andto thread the barbed and/or leading portions 108, 106 therethrough. Asshown in FIG. 1, an embodiment of the threader 120 can include asuture-engaging feature 122, a stem 124, and a pull tab 126. An entiretyof the threader 120 can be configured to pass through the hollow portion112. The threader 120 can be made from one or more materials that aresufficiently flexible to allow for passage of the threader 120 inthrough the wall 115 of the hollow portion 112, through at least aportion of the passageway 116, and out through the wall 115. In anexemplary embodiment, prior to use in a surgical procedure, the threader120 can be inserted through the hollow portion 112 such that the stem124 is positioned at least partially within the hollow portion 112, asshown in FIG. 2. Although the threader 120 can have any orientation whenthe threader 120 is at least partially within the hollow portion 112, inan exemplary embodiment the suture-engaging feature 122 of the threader120 can extend through the wall 115 of the hollow portion 112 at aposition adjacent to the trailing end 104, and the pull tab 126 canextend from an opposite end of the stem 124 and through the wall 115 ata position adjacent to the barbed portion 108. The suture-engagingfeature 122 can be any feature configured to securely engage the leadingend 102 of the suture 100. In the illustrated embodiment, thesuture-engaging feature 122 is an eyelet having a size that allows forthe passage of the suture 100, including the barbed portion 108,therethrough. The pull tab 126 can be configured to allow for grippingby a user to help pull a portion of the suture 100 that is mated to thesuture-engaging feature 122 through the passageway 116 and/or the wall115 of the hollow portion 112.

The suture 100 can be configured to approximate a variety of types oftissue, either the same or different from one another. Where the suture100 is being used to approximate tissue that includes at least one bonystructure, the suture 100 can be configured for use with a bone anchor.The bone anchor can be any bone anchor known in the art, and can beconfigured to secure the suture 100 to the bony structure. Inparticular, the bone anchor can have a suture-engaging feature, e.g., aneyelet, that is large enough for passage of the barbed portion 108therethrough.

The suture 100 can be configured for use with an elongate tubular memberto facilitate passage of the suture 100 through an incision in apatient's body and to a surgical site, such as in an arthroscopicprocedure. The elongate tubular member can be, e.g., a trocar, deliverytube, endoscopic tunnel, cannula, etc, and can have a passagewaytherethrough extending between proximal end distal ends thereof. Thepassageway can be wide enough to allow at least two strands of thesuture 100 to pass therethrough and can be long enough to extend betweenthe incision and the surgical site.

The sutures disclosed herein can be generally used to approximate tissuewithout tying a knot in a variety of surgical procedures. For example, asuture can be used in a cuff repair procedure in which the suture isused to approximate tissues of a torn rotator cuff. In an exemplaryembodiment, a barbed suture can be used to approximate two pieces ofsoft tissue.

In use, a suture can be inserted into a body of a patient in accord withcustomary surgical procedures, which can include open surgery orminimally invasive surgery, e.g., using a cannula. The suture 100 can beused, for example, in an exemplary surgical procedure shown in FIGS.3A-3D. Although this procedure is illustrated using the suture 100 andthe threader 120 of FIG. 1, other sutures disclosed herein can be usedand another threader or no threader can be used.

As shown in FIG. 3A, the leading end 102 of the suture 100 can be passedthrough a cannula 130, through a first soft tissue T1, through a secondsoft tissue T2, and back through the cannula 130 so as to have twostrands of the leading portion 106 extending through the cannula 130.The suture 100 can be passed through the cannula 130 in any way, forexample using a needle (not shown) attached to the leading end 102 ofthe suture 100. Although the cannula 130 is used to introduce the suture100 into the patient's body in the illustrated embodiment, anothercannula or other introducer device can be used to introduce the suture100 into the body.

The leading end 102 of the suture 100 can be mated to thesuture-engaging feature 122 of the threader 120, e.g. by threading, asshown in FIG. 3B. The pull tab 126 of the threader 120 can be pulled,e.g., by a surgeon, a robotic controller, etc., to splice the hollowportion 112 and form a loop 140, as shown in FIG. 3C. The leading end102 of the suture 100 can be pulled to adjust a size of the loop 140 toa desired size, for example to a size at which a user pulling the suture100 feels sufficient tension in the suture 100. Because the barbs 118all extend in the direction D1 in which the suture 100 is being pulled,the barbed portion 108 can pass easily through the wall 115 and thepassageway 116 of the hollow portion 112. When the loop 140 has beenreduced to the desired size, at least a part of the barbed portion 108can be disposed within the hollow portion 112, as shown in FIG. 3D. Asmentioned above, the barbed portion 108 can be coaxial with the hollowportion 112 when disposed therein, as shown in FIG. 3D. In the exemplaryembodiment shown in FIG. 3D, the barbed portion 108 extends all the waythrough the length L4 of the hollow portion 112 so as to maximize thenumber of barbs 118 contained within the hollow portion 112. Thuspositioned, the barbs 118 can grasp the wall 115 of the hollow portion112 and/or the tissue T2 to prevent loosening of the loop. Additionally,the barbs 118 that are not positioned within the hollow portion 112 canhelp to secure the suture 100 in position by digging into the secondsoft tissue T2.

The barbs' resistance to movement can change depending on a direction ofmovement of the suture 100 and/or a tension that is applied to thesuture 100. For example, as the barbed portion 108 passes through thepassageway 116 of the hollow portion 112 in the first direction D1, theangle α of the barbs 118 with respect to the suture 100 can decrease,thus facilitating movement of the suture 100 in the first direction D1.Movement of and/or tension applied to the barbed portion 108 in thesecond direction D2 can cause the angle α of the barbs 118 with respectto the suture 100 to increase, thereby causing the barbs 118 to digfarther into the inner wall 115 and/or into tissue and increasing aresistance of the barbs 118 to movement in the second direction D2.Where tension is applied to the suture 100 in both the first and seconddirections D1 and D2, a diameter of the passageway 116 of the hollowportion 112 can decrease and/or the angle α of the barbs 118 withrespect to the suture 100 can increase, both of which can cause thebarbs 118 to dig deeper into the wall 115. In this way, the barbs 118can provide strong resistance against any force and/or movement thatwould tend to cause the loop of the suture 100 to expand after the loop140 has been tensioned to the desired size. The loop's desired size canvary for different tissues and/or different surgical procedures. In acuff convergence procedure, the loop 140 can have a diameter in a rangeof about 10 to 15 mm.

Once the loop 140 of suture 100 has been reduced to the desired size,thereby securely approximating the tissue T1 and T2, the cannula 130 canbe removed from the patient's body. In some embodiments, however, thecannula 130 can be removed before tightening of the suture 100 to formthe reduced size loop 140. At least a portion of the leading portion 106and/or the barbed portion 108 can be trimmed to remove excess suturefrom the surgical site.

A person skilled in the art will appreciate that the present inventionhas application in conventional minimally-invasive and open surgicalinstrumentation as well application in robotic-assisted surgery.

The devices disclosed herein can also be designed to be disposed ofafter a single use, or they can be designed to be used multiple times.In either case, however, the device can be reconditioned for reuse afterat least one use. Reconditioning can include any combination of thesteps of disassembly of the device, followed by cleaning or replacementof particular pieces and subsequent reassembly. In particular, thedevice can be disassembled, and any number of the particular pieces orparts of the device can be selectively replaced or removed in anycombination. Upon cleaning and/or replacement of particular parts, thedevice can be reassembled for subsequent use either at a reconditioningfacility, or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that reconditioningof a device can utilize a variety of techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims.

What is claimed is:
 1. A suturing system, comprising: a flexible suturehaving leading and trailing ends, the suture having a first partiallongitudinal length with a plurality of unidirectional barbs, and asecond partial longitudinal length having a hollow portion, the hollowportion being located between the trailing end of the suture and theplurality of unidirectional barbs, and the leading end of the suturebeing configured to pass through the hollow portion so as to move atleast one of the barbs into the hollow portion such that the at leastone of the barbs grasps onto the suture within the hollow portionthereof.
 2. The system of claim 1, wherein, when the at least one of thebarbs is positioned within the hollow portion, the first partiallongitudinal length is coaxial with the hollow portion of the secondpartial longitudinal length.
 3. The system of claim 1, wherein the firstpartial longitudinal length of the suture is longer than the hollowportion of the second partial longitudinal length of the suture.
 4. Thesystem of claim 3, wherein a third partial longitudinal length of thesuture extends between the barbs and the leading end, and wherein thethird partial longitudinal length is longer than each of the first andsecond partial longitudinal lengths of the suture.
 5. The system ofclaim 1, wherein the suture comprises a single strand including thebarbs and the hollow portion.
 6. The system of claim 1, wherein thebarbs are configured to grasp soft tissue so as to prevent movement ofthe suture relative to the soft tissue in a direction opposite to theunidirection of the barbs.
 7. The system of claim 1, further comprisinga threader positioned within the hollow portion of the suture, theleading end of the suture being configured to mate to the threader andthe threader being configured to be pulled through the hollow portionwith the leading end mated therewith so as to pass the leading end ofthe suture into the hollow portion and move the leading end therethroughsuch that at least one of the barbs is moved into the hollow portion. 8.The system of claim 1, further comprising a cannula, the suture beingconfigured to pass through the cannula, into a soft tissue, and passback through the cannula so as to position a free end of the sutureoutside the cannula and to position the barbs outside the soft tissue,the free end positioned outside the cannula being configured to be movedrelative to the cannula so as to move the barbs into the soft tissue andinto the hollow portion of the suture.
 9. A suturing system, comprising:a flexible suture having a free end configured to enter into a hollowportion of the suture and pass through the hollow portion in a firstdirection so as to move a plurality of unidirectional barbs extendingoutward from the suture along a length of the suture into the hollowportion, the barbs being configured to grasp onto the suture within thehollow portion so as to prevent the length of the suture from movingwithin the hollow portion in a second direction that is opposite to thefirst direction.
 10. The system of claim 9, wherein the barbs extendalong a length of the suture that is greater than a length of the hollowportion such that all of the barbs cannot be simultaneously positionedwithin the hollow portion.
 11. The system of claim 9, wherein the barbspositioned within the hollow portion that grasp onto the suture withinthe hollow portion are configured to lock the length of the suture in afixed position relative to the hollow portion of the suture.
 12. Thesystem of claim 9, wherein, when a length of the suture is positionedwithin the hollow portion, the length of the suture is coaxial with thehollow portion of the suture.
 13. The system of claim 9, wherein thebarbs are configured to grasp soft tissue so as to prevent movement ofthe suture relative to the soft tissue in a direction opposite to theunidirection of the barbs.
 14. The system of claim 9, further comprisinga threader positioned within the hollow portion of the suture, the freeend of the suture being configured to mate to the threader, and thethreader being configured to be pulled through the hollow portion withthe free end mated therewith to thereby pull the free end of the sutureinto the hollow portion and position one or more of the barbs within thehollow portion.
 15. The system of claim 9, further comprising a cannula,the suture being configured to pass through the cannula, into a softtissue, and pass back through the cannula so as to position a free endof the suture outside the cannula and to position the barbs outside thesoft tissue, the free end positioned outside the cannula beingconfigured to be moved relative to the cannula so as to move the barbsinto the soft tissue and into the hollow portion of the suture.
 16. Asurgical method, comprising: advancing a leading end of a suture into afirst tissue; advancing the leading end of the suture into a secondtissue; advancing the leading end of the suture into a hollow portion ofthe suture so as to form a loop; and pulling the leading end of thesuture relative to the hollow portion, the first tissue, and the secondtissue so as to advance a plurality of unidirectional barbs formed onthe suture through the first tissue, through the second tissue, and intothe hollow portion, the plurality of unidirectional barbs grasping thesuture within the hollow portion so as to lock the suture in positionrelative to the first and second tissues.
 17. The method of claim 16,wherein a length of the suture extending through the hollow portion iscoaxial with the hollow portion.
 18. The method of claim 16, wherein theleading end of the suture is advanced into the hollow portion of thesuture after the leading end of the suture has been advanced into thefirst tissue and advanced into the second tissue.
 19. The method ofclaim 16, further comprising, advancing the leading end of the suturethrough a cannula prior to advancing the leading end into the firsttissue, and advancing the leading end of the suture back into thecannula after advancing the leading end into the second tissue.
 20. Themethod of claim 16, wherein pulling the leading end of the suture causesthe first and second tissues to be drawn together.